Skip to main content
OSTI.GOVU.S. Department of Energy Office of Scientific and Technical Information
U.S. Department of Energy
Office of Scientific and Technical Information
 

In Vitro Thrombogenicity Testing of Biomaterials in a Dynamic Flow Loop: Effects of Length and Quantity of Test Samples

Journal Article · · Journal of Medical Devices
DOI:https://doi.org/10.1115/1.4062863· OSTI ID:2425710
; ; ;
Abstract

The results of in vitro dynamic thrombogenicity testing of biomaterials and medical devices can be significantly impacted by test conditions. To develop and standardize a robust dynamic in vitro thrombogenicity tool, the key test parameters need to be appropriately evaluated and optimized. We used a flow loop test system previously developed in our laboratory to investigate the effects of sample length and the number of samples per test loop on the thrombogenicity results. Porcine blood heparinized to a donor-specific target concentration was recirculated at room temperature through polyvinyl chloride (PVC) tubing loops containing test materials for 1 h at 200 mL/min. Four test materials (polytetrafluoroethylene (PTFE), latex, PVC, and silicone) with various thrombotic potentials in two sample lengths (12 and 18 cm) were examined. For the 12-cm long materials, two different test configurations (one and two samples per loop) were compared. Thrombogenicity was assessed through percent thrombus surface coverage, thrombus weight, and platelet count reduction in the blood. The test system was able to effectively differentiate the thrombogenicity profile of the materials (latex > silicone > PVC ≥ PTFE) at all test configurations. Increasing test sample length by 50% did not significantly impact the test results as both 12 and 18 cm sample lengths were shown to equally differentiate thrombotic potentials between the materials. The addition of a second test sample to each loop did not increase the test sensitivity and may produce confounding results, and thus a single test sample per loop is recommended.

Research Organization:
Oak Ridge Institute for Science and Education (ORISE), Oak Ridge, TN (United States)
Sponsoring Organization:
USDOE Office of Science (SC)
DOE Contract Number:
SC0014664
OSTI ID:
2425710
Journal Information:
Journal of Medical Devices, Journal Name: Journal of Medical Devices Journal Issue: 3 Vol. 17; ISSN 1932-6181
Publisher:
American Society of Mechanical Engineers (ASME)
Country of Publication:
United States
Language:
English

References (23)

Thrombogenicity Testing of Medical Devices in a Minimally Heparinized Ovine Blood Loop journal May 2017
Preclinical Evaluation of the Thrombogenicity and Endothelialization of Bare Metal and Surface-Coated Neurovascular Stents journal September 2014
An In Vitro Blood Flow Loop System for Evaluating the Thrombogenicity of Medical Devices and Biomaterials journal February 2020
Comparison of catheter thrombogenicity in a modified chandler loop model using goat blood journal September 2018
Hemocompatibility testing according to ISO 10993-4: Discrimination between pyrogen- and device-induced hemostatic activation journal September 2014
Neurovascular Rescue journal June 2005
Effect of Temperature on Thrombogenicity Testing of Biomaterials in an In Vitro Dynamic Flow Loop System journal February 2023
Thrombogenicity assessment of Pipeline Flex, Pipeline Shield, and FRED flow diverters in an in vitro human blood physiological flow loop model journal September 2018
Bleeding and Thrombosis in Patients With Continuous-Flow Ventricular Assist Devices journal June 2012
Biomaterial testing for covered stent membranes: Evaluating thrombosis and restenosis potential journal September 2011
Shear Stress‐Induced Total Blood Trauma in Multiple Species journal July 2017
An in vitro model for preclinical testing of thrombogenicity of resorbable metallic stents journal October 2014
Haemodilution-induced changes in coagulation and effects of haemostatic components under flow conditions journal December 2013
Frequency and predictors of thrombus inside the guiding catheter during interventional procedures: an optical coherence tomography study journal October 2014
Comparison of animal and human blood for in vitro dynamic thrombogenicity testing of biomaterials journal July 2022
A novel approach to extraction of a large thrombus on the intraventricular guide‐wire during transcatheter aortic valve replacement journal September 2015
In Vitro Thrombogenicity Testing of Artificial Organs journal September 1998
Nonthrombogenic Approaches to Cardiovascular Bioengineering journal August 2011
In vitro hemocompatibility studies of drug-loaded poly-(l-lactic acid) fibers journal December 2003
The optimal incubation time for in vitro hemocompatibility testing: Assessment using polymer reference materials under pulsatile flow with physiological wall shear stress conditions
  • Blok, Sjoerd Leendert Johannes; van Oeveren, Willem; Engels, Gerwin Erik
  • Journal of Biomedical Materials Research Part B: Applied Biomaterials, Vol. 107, Issue 7 https://doi.org/10.1002/jbm.b.34326
journal January 2019
Thrombogenicity testing of central venous cathetersin vitro journal January 1999
Sheep, pig, and human platelet-material interactions with model cardiovascular biomaterials journal June 1999
Comparing techniques: the use of recalcified plasma in comparison with citrated plasma alone and in combination with thrombin in ultrastructural studies journal November 2011

Similar Records

Related Subjects

Engineering